Market Authorization

 
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Enanta Announces European Commission Grants Marketing Authorizations for AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Genotypes 1 and 4 Chronic Hepatitis C Virus Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Commission has granted marketing authorizations for AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) 1,2 with or without ribavirin (RBV) for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.
Sign-up for Enanta Announces European Commission Grants Marketing Authorizations for AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)... investment picks
RHB-102, newly branded as BEKINDA ™ , is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron The European marketing authorization application (MAA) seeks approval of BEKINDA ™ for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting BEKINDA ™ is also being developed for acute gastroenteritis and gastritis, with a Phase III study ongoing in the U.S. and top-line data expected during H2/2015 TEL-AVIV, Israel, Dec.
Sign-up for RedHill Biopharma Submits BEKINDA(TM) (RHB-102) European Marketing Authorization Application for Oncology Support investment picks
AVEO Oncology (NASDAQ:AVEO) today announced that it has received written confirmation from the European Medicine Agency (EMA) that tivozanib is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure.
Sign-up for AVEO Receives Confirmation of Eligibility for Submission of a Tivozanib Marketing Authorization Application to the European Medicines Agency investment picks
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) of ELOCTA ™ (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of hemophilia A.
Sign-up for Biogen Idec and Sobi Announce European Medicines Agency Validates ELOCTA™ (rFVIIIFc) Marketing Authorization Application for Review investment picks
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Medicines Agency (EMA) has validated and initiated its review of the company’s marketing authorization application (MAA) for Natpar ® (parathyroid hormone (rDNA)) for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH). If approved, Natpar would be the first and only PTH replacement therapy in Europe for patients with Hypoparathyroidism.
Sign-up for European Medicines Agency Validates Marketing Authorization Application for Natpar® (parathyroid hormone (rDNA)) in Hypoparathyroidism investment picks
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Pfizer has received EU marketing authorization for DUAVIVE® (conjugated estrogens/bazedoxifene (BZA/CE)) from the European Commission.
Sign-up for Ligand Partner Pfizer Receives European Marketing Authorization for DUAVIVE® (Conjugated Estrogens/Bazedoxifene) for Treatment of Estrogen Deficiency Symptoms in Postmenopausal Women with a Uterus investment picks
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
Sign-up for European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 investment picks
pSivida Corp.
Sign-up for pSivida Reports ILUVIEN® Granted Marketing Authorization in Ireland investment picks
- In Phase 3 clinical trials, VIEKIRAX + EXVIERA cured 95-100 percent of genotype 1 chronic hepatitis C patients, with less than 2 percent of patients experiencing virologic failure[1],[2] - Tolerability profile shows more than 98 percent of patients completed a full course of therapy[3] - All-oral, interferon-free regimen also approved for HCV/HIV-1 co-infection, patients on opioid substitution therapy and patients who have undergone a liver transplant[1],[2] - VIEKIRAX + EXVIERA are the first products to be approved as a combination treatment of three direct-acting antivirals with distinct mechanisms of action targeting hepatitis C at multiple steps in the viral lifecycle[1],[2] NORTH CHICAGO, Ill.
Sign-up for European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C investment picks
pSivida Corp.
Sign-up for pSivida Reports ILUVIEN® Granted Marketing Authorization in Belgium investment picks

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Market Authorization
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